(1)If a manufacturer or authorized agent, as the case may be, considers or has reasons to believe that a medical device, which has been imported, manufactured, sold or distributed, is likely to pose risk to the health of a user or patient during its use and therefore may be unsafe, such manufacturer or authorized agent shall immediately initiate procedures to withdraw the medical device in question from the market and patients, indicating reasons for its withdrawal and inform the competent authority the details thereof.
